Companion Diagnostics and Personalized Medicine Market Report 2012

July 2012 | 130 pages | ID: CECF02C5975EN
Select Biosciences Ltd.

Abstracts

Up-to-Date Market Analyses of the CDx Field

This is the latest and most up-to-date Market Report from Select Biosciences addressing the companion diagnostics (CDx) and personalized medicine marketplace. Personalized medicine is a broad field with several stakeholders all of which must be aligned in order to capture the immense potential value in targeting therapeutics to the correct patient population—the field of stratified medicine.

Companion Diagnostics has been rapidly expanding over the past 3 years and in this market report we describe the current state of the marketplace from the following perspectives:

• All the Prognostic and Predictive Biomarkers with Potential Clinical Utility are described—a few have already been developed into CDx and we expect growth in this space
• Targeted Therapeutics, Associated Biomarkers, Therapeutic Indications, and Testing Mandates are Described
• Companion Diagnostics Partnerships and Collaborations from 2009 to 2012 are Presented—Provides an Up-to-Date State of the Industry Describing the Disease Areas being Addressed and Types of Biomarkers Being Deployed
• Quantitative Market Metrics
• Quantitative Market Forecast: Market Sizing and Growth Rate
• Revenue Breakout: Rx versus Dx
• Targeted Rx and CDx Pricing
• Publication Hotspot Analyses of the Various Cancer Biomarker Classes for Identifying Niches of Market Opportunity in Various Disease Classes

This data-driven characterization of the Companion Diagnostics and Personalized Medicine field is a hands-on document that can be used for competitive benchmarking, business planning, and strategy development—all the data that have been collected in this industry analysis are presented and they form the basis for the conclusions drawn throughout the market report presented in a format enabling “drag-and-drop” into business presentations/business plans—this Market Report is written and delivered to customers in PowerPoint format.

Extensive Market Analyses Presented in this Report

Personalized Medicine and Companion Diagnostics: Market Segmentation and Quantitative Analysis

• Prognostic Biomarkers in Cancer Listing, Description, and Clinical Significance
• Predictive Biomarkers in Cancer Listing, Description, and Clinical Significance
• Summary of Pathways to Regulatory Approval of Companion Diagnostics
• LDTs under CLIA Certification
• Outcomes with Drugs in Various Disease Classes
• Percent of Tumor Classes where Tumors are Associated with Characterized Somatic Mutations
• Companion Diagnostics and Personalized Medicine: Quantitative Market Metrics
• How Much Does it Cost to Develop a Companion Diagnostic?
• Precedent for Premium Pricing in Cancer Targeted Therapeutics
• Pricing of Selected Personalized Medicine Tests
• Growth of the Personalized Medicine Marketplace: Market Size/Forecast and Growth Rate

Personalized Medicine Industry Landscape: Selected Indications, Biomarkers and Therapeutics

Market Trends and Evolution of the CDx Marketplace

• Disparities between Rx and CDx Companies
• Varying Economic Incentives between Rx and Dx Development
• Increasing Targeted Rx in the Oncology Space and Effect on CDx Development
• Current Rx/CDx Co-development Programs in Phase III Trials with Listing of Associated Biomarkers
• Cancer Classes Addressable by CDx
• Characterization of Molecular Biomarker Classes: Hotspot Analysis of Publications
• Cancer Biomarkers
• Oncogenes
• Tumor Suppressor Genes
• Non-coding RNAs
• Collaborations and Partnering in the CDx Space
• 2012
• 2011
• 2010
• 2009

Contents

CHAPTER I. PERSONALIZED MEDICINE AND COMPANION DIAGNOSTICS: MARKET SEGMENTATION AND QUANTITATIVE ANALYSIS

Definition of Companion Diagnostics
Classes of Biomarkers and their Utility in Personalized Medicine
Prognostic Biomarkers in Cancer Listing, Description, and Clinical Significance
Predictive Biomarkers in Cancer Listing, Description, and Clinical Significance
Challenges for the Broader Personalized Medicine Field and its Adoption
Summary of Pathways to Regulatory Approval of Companion Diagnostics
LDTs under CLIA Certification
Outcomes with Drugs in Various Disease Classes
Percent of Tumor Classes where Tumors are Associated with Characterized Somatic Mutations
Somatic Mutation Sequelae in Lung Cancer and Gastrointestinal Cancers
Xalkori® Story
Zelboraf® Story
Companion Diagnostics and Personalized Medicine: Quantitative Market Metrics
   How Much Does it Cost to Develop a Companion Diagnostic?
   Precedent for Premium Pricing in Cancer Targeted Therapeutics
   Pricing of Selected Personalized Medicine Tests
   Growth of the Personalized Medicine Marketplace: Market Size/Forecast and Growth Rate

CHAPTER II. PERSONALIZED MEDICINE INDUSTRY LANDSCAPE: SELECTED INDICATIONS, BIOMARKERS AND THERAPEUTICS

Therapeutic
Biomarker
Indication
Testing Mandate
This comprehensive listing frames the various personalized medicine tests that are either "Required", "Recommended", "For Information Use Only", or "With N  Pharmacogenomic Information on the Drug Label"

CHAPTER III. MARKET TRENDS AND EVOLUTION OF THE CDX MARKETPLACE TIMELINE OF RX/CDX CO-DEVELOPMENT OVER THE LAST TW DECADES

Disparities between Rx and CDx Companies
Varying Economic Incentives between Rx and Dx Development
Increasing Targeted Rx in the Oncology Space and Effect on CDx Development Current Rx/CDx Co-development Programs in Phase III Trials with Listing Associated Biomarkers
Cancer Classes Addressable by CDx
Characterization of Molecular Biomarker Classes: Hotspot Analysis of Publications Cancer Biomarkers
Oncogenes
Tumor Suppressor Genes
Non-coding RNAs
Collaborations and Partnering in the CDx Space
  2012
  2011
  2010
  2009

APPENDIX I. RESEARCH METHODOLOGY

APPENDIX II. LISTING AND DESCRIPTION OF CANCER BIOMARKERS